Stimulator, Autonomic Nerve, Implanted (Depression)
FDA adverse event reports and recall history for stimulator, autonomic nerve, implanted (depression) (product code MUZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,363
- Deaths
- 77
- Injuries
- 1,115
- Malfunctions
- 1,157
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- TerminatedDevice Design
VNS Therapy Programmer, Model 3000, v1.0 System
Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (Model 106 only); " No stimulation in the case of device disablement (Burst Watchdog Timeout), resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved within device specification (Models 103, 104, 105, or 106); and/or " Delays or absence of the 75% and 50% battery life indicators displayed by the programming software (Models 103, 104, 105, or 106).
Monitor stimulator, autonomic nerve, implanted (depression) automatically
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